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Completed

NCT Number: NCT01330381

Prucalopride in Pediatric Subjects With Functional Constipation

To evaluate the efficacy of prucalopride compared to placebo for the treatment of functional constipation in a paediatric population, aged ≥ 6 months to < 18 years. A 16-week open-label comparator (PEG) controlled part will follow, to document safety and tolerability up to 24 weeks.

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Key information

Conditions

Functional Constipation

Age range

6 month–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Academisch Medisch Centrum

Amsterdam, 1105 AZ, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Main Inclusion Criteria:

  • Boys and girls, aged ≥ 6 months and < 18 years.
  • Subjects with a confirmed diagnosis of functional constipation as defined by the Rome III criteria.

Main Exclusion Criteria:

  • Children with underlying GI abnormalities and causes for defecation disorders.
  • Constipation is thought to be drug-induced.
  • Subjects suffering from secondary causes of chronic constipation.

Treatment and study plan

prucalopride

Drug

prucalopride

  • subjects with weight ≤50kg: 0.04 mg/kg once daily as oral solution of 0.4 mg/ml
  • subjects with weight >50 kg: prucalopride 2 mg tablet once daily

Placebo

Drug

Matching oral solution or oral tablets given once daily

PEG 4000

Drug

Primary outcomes

  1. Percent of Responders in the Last Four Weeks of the Double-Blind Treatment Period

    Time frame: Last 4 weeks of double-blind treatment period

    Responders are defined as subjects with an average spontaneous defecation frequency is ≥3 times per week AND the average number of fecal incontinence episodes per 2 weeks is ≤ 1 episode (only for subjects after acquisition of toileting skills).

Secondary outcomes

  1. Percent of Subjects With Bowel Frequency of 3 or More Spontaneous Bowel Movements (SBM) Per Week in the Last Four Weeks of the Double-Blind Treatment Period

    Time frame: Last 4 weeks of double-blind treatment period

    Spontaneous Bowel Movements defined as a bowel movement that is not preceded within a period of 24 hours by the intake of a laxative agent or by the use of an enema.

  2. Percent of Subjects With Fecal Incontinence Episodes of 1 or Less Per 2 Weeks in the Last Four Weeks of the Double-Blind Treatment Period

    Time frame: Last 4 weeks of double-blind treatment period

    Fecal incontinence is a lack of control over defecation, leading to involuntary loss of bowel contents (only for subjects after acquisition of toileting skills).

  3. Number of Retentive Posturing or Excessive Volitional Stool Retention in the Double-Blind Treatment Period

    Time frame: Over the 8 week double blind treatment period

    Purposefully avoiding defecation.

  4. Painful Bowel Movements Score in the Double-Blind Treatment Period

    Time frame: Over the 8 week double blind treatment period

    Pain was rated on a 6-point scale (0=no hurt, 1=hurts little bit, 2=hurts little more, 3=hurts even more, 4=hurts whole lot, 5=hurts worst) in subjects of 3 years and older. Lower scores represent less pain.

  5. Stool Consistency Per SBM Score in Children Without Diapers in the Double-Blind Treatment Period

    Time frame: Over the 8 week double blind treatment period

    Measured using the 7-point Bristol scale where 1-2 indicate constipation, 3-4 are ideal stools, and 5-7 tending toward diarrhea.

  6. Stool Consistency Per SBM Score in Children With Diapers in the Double-Blind Treatment Period

    Time frame: Over the 8 week double blind treatment period

    Measured on a 4-point scale where 1 is constipation, 2-3 is ideal, and 4 is diarrhea.

  7. Large Diameter Stools in the Double-Blind Treatment Period

    Time frame: Over the 8 week double blind treatment period

    Large diameter stools make defecation more difficult. Small diameter stools are better.

  8. Abdominal Pain Score in Double-Blind Treatment Period

    Time frame: Over the 8 week double blind treatment period

    Pain was rated on a 6-point scale (0=no hurt, 1=hurts little bit, 2=hurts little more, 3=hurts even more, 4=hurts whole lot, 5=hurts worst) in subjects of 3 years and older. Lower scores represent less pain.

  9. Frequency of Toilet Training in the Double-Blind Treatment Period

    Time frame: Over the 8 week double blind treatment period

    Only for subjects after acquisition of toileting skills.

  10. Number of Rescue Medications Taken in the Double-Blind Treatment Period

    Time frame: Over the 8 week double blind treatment period

  11. Time to First SBM in the Double-Blind Treatment Period

    Time frame: Day 1 onwards

    After intake of the trial medication on Day 1.

  12. Number of SBM Per Week in the Double-Blind Treatment Period

    Time frame: Over the 8 week double blind treatment period

  13. Change From Baseline in the Number of SBM Per Week Over the 8 Week Double Blind Treatment Period

    Time frame: Baseline and over the 8 week double blind treatment period

  14. Severity of Constipation Over the Past 2 Weeks for the Final On Treatment Assessment in the Double-Blind Treatment Period

    Time frame: 2 weeks

  15. Severity of Constipation Over the Past 2 Weeks for the Final On Treatment Assessment in the Open-Label Treatment Period

    Time frame: 2 weeks

  16. Efficacy of Treatment for Final On Treatment Assessment in Double-Blind Treatment Period

    Time frame: Over the 8 week double blind treatment period

  17. Efficacy of Treatment for Final On Treatment Assessment in Open-Label Treatment Period

    Time frame: Over the 16 week open label treatment period

  18. Convenience of Treatment for Final On Treatment Assessment in Open-Label Treatment Period

    Time frame: Over the 16 week open label treatment period

Sponsors and collaborators

Lead sponsor

Shire

Industry

Collaborators

  • PRA Health Sciences

Registry information

Official study title

Trial Consisting of an 8-week Double-blind Placebo-controlled Part to Evaluate Efficacy, Safety, Tolerability and Pharmacokinetics of Prucalopride in Paediatric Subjects With Functional Constipation, Aged ≥6 Months to <18 Years, Followed by a 16-week Open-label Comparator (PEG) Controlled Part, to Document Safety and Tolerability up to 24 Weeks

Acronym: FC

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Apr 6, 2011
Registry last updated
Jun 10, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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